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Vocal-cord vs. Complete Laryngeal Radiotherapy for Early Glottic Cancer

Larynx Cancer | Cancer Neck | Glottis Tumor

This is a multicentrer, randomized Bayesian Phase II trial for patients with early stage (T1N0) glottic squamous cell carcinoma treated with radical radiotherapy. The primary objective is to assess the non-inferiority of local control achieved with vocal-cord only radiotherapy (VC-RT) compared to complete larynx radiotherapy (CL-RT) in T1N0 glottic laryngeal squamous cell cancer, measured at 2-years after treatment. Secondary outcomes include overall survival, as well as voice impairment, dysphagia and quality of life, measured respectively by the voice handicap index -10 (VHI-10), the MD Anderson Dysphagia Inventory (MDADI) and the MD Anderson Symptom Inventory- Head and Neck module (MDASI-HN). Patients will be randomized in a 1:3 ratio to CL-RT (39 patients) and VC-RT (116 patients) arms. There will be stratification by tumor stage (T1a/T1b) and by institution. An interim analysis is planned after the first 55 patients enrolled on the experimental arm have a 6-month follow-up.

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Conditions de participation

  • Sexe:

    ALL

  • Âges admissibles:

    18 and up

Critères de participation

Inclusion Criteria:

* Stage T1a-b N0 of the true vocal cords planned for definitive RT
* Patient not candidate for laser surgery or declined laser surgery
* Biopsy-confirmed squamous cell carcinoma, including verrucous carcinoma
* Eastern Cooperative Oncology Group performance status 0-2
* Ability to provide written informed consent.

Exclusion Criteria:

* Previous irradiation of the head and neck (HNC) region
* Pregnancy or breastfeeding
* Any medical condition that represents, in the opinion of the investigator, a contraindication to radiotherapy or would prevent follow-up after radiotherapy.
* Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 2 years.

Lieu de l'étude

Centre Hospitalier de l'Université de Montréal
Centre Hospitalier de l'Université de Montréal
Montreal, Quebec
Canada

Contactez l'équipe d'étude

Primary Contact

Diane Trudel

[email protected]
514-890-8000
London Health Sciences Centre
London Health Sciences Centre
London, Ontario
Canada

Contactez l'équipe d'étude

Primary Contact

Patricia Moore

[email protected]
519-685-8500
Étude parrainée par
Centre hospitalier de l'Université de Montréal (CHUM)
Participants recherchés
Plus d'informations
ID de l'étude: NCT03759431